Vibrating surgical instrument for liposuction and other body contouring applications

ABSTRACT

A vibrating hand held surgical instrument for loosening tissue of a patient for liposuction or body contouring procedures. The instrument includes a motor connected to a vibration actuator having an eccentric rotating mass and an end effector for engaging tissue operatively connected to the vibration actuator, wherein the motor rotates the eccentric mass to cause the end effector to vibrate to loosen tissue. A flexible shaft having first end and second ends dampen the vibration to the motor and to the operator handle.

This application claims priority to provisional application Ser. No.62/832,281, filed Apr. 10, 2019, the entire contents of which areincorporated herein by reference.

BACKGROUND Field of the Invention

The present invention is directed to a hand held vibrating device forliposuction and other body contouring surgical procedures.

Background

Liposuction is one of the most commonly performed surgical procedures.Liposuction is a procedure which slims and reshapes areas of the bodyfor removing excess fat and improving body contours. Liposuction can beutilized for therapeutic reasons such as treating obesity or forcosmetic reasons to improve appearance. Liposuction is also frequentlyperformed to harvest fat tissue that can be re-injected as autologousgrafts to augment areas of volume deficiencies such as women's breastsafter cancer resection. The procedure consists of making an incision,inserting a cannula into the space occupied by the fat tissue andsuctioning the fat through the cannula that the surgeon's arm advancesback and forth through the tissues. The procedure is often quiteinefficient, requiring a significant amount of physical effort on thepart of the surgeon, especially since to minimize the entry siteincision and therefore the size of the resultant scar, the caliber(diameter) of the cannula is limited to 2-5 mm. This limits the entrysite to few anatomical areas where the scar can be hidden andsubsequently to the tissue region effected (loosened/broken up) bycannula movement. Another significant complication from such liposuctiontechnique is unsightly surface contour irregularity that may result ifthe fat is unevenly harvested.

One of the existing techniques that is reported to reduce surgeonfatigue and help in the process uses a power-assisted liposuction device(PAL). An example of such device is disclosed in U.S. Pat. No.5,911,700. The device adds to the surgeon's motion a 1-3 mm to-and-froreciprocating motion of the cannula in the 40-90 Hz frequency rangesimilar to that of a jackhammer. While this procedure is often referredto as vibration liposuction, the device does not truly vibrate butrather causes the cannula to reciprocate along the same linear(longitudinal) axis. The PAL technique reduces surgeon effort but theharvesting is still through the same linear channel ploughed by thecannula, thereby limiting the region effected by the device toessentially the cannula diameter.

Another device designed to help with liposuction is disclosed in U.S.Pat. No. 9,457,177 and claims to impart to the cannula a nutationalmotion that comprises a combination of a to-and-fro motion along withsome vibration at the tip, depending upon the cannula length. However,the mechanism involved in this device does not directly induce vibrationbut instead, by using sudden hammer-like strikes of a piston moving backand forth inside a channel, delivers to the cannula some vibrationeffect in addition to the alternating back-and-forth movement.

Another device also designed to help with liposuction (Vibrasat®,Moeller Medical) imparts to the cannula an arcuate pendulum like motionto supposedly help loosen the tissues and harvest more efficiently. Thisis considered by some as an improvement over the PAL because in additionto harvesting out of the same ploughed tunnel like the reciprocatingPAL, the sweeping motion harvests along an additional linear transversepath.

It is desirable to limit the size of the incision for liposuction forcosmetic reasons as well as reducing tissue trauma and patient recoverytime. However, with such small incision, the foregoing devices arelimited in their range of tissue harvesting. Therefore, it would beadvantageous to increase the range of tissue harvesting withoutincreasing the size of the incision.

Furthermore, the foregoing devices oftentimes create contour defects. Itwould be advantageous to provide a liposuction device that can betterre-drape and help avoid the surface contour defect complications.

Low frequency vibration applied to biologic tissues can loosen theirfibrovascular structural framework with less risk of damage than directsudden strong striking force. A number of household items (e.g.,toothbrushes, shavers, or the like) and industrial devices (e.g.,vibrating tables, funnels, compactors, or the like) depend on vibrationto reduce friction and to improve the flow, compaction, and/or diffusionof particulate matter, fluids, and/or air bubbles. Some medical devicesalso use low frequency vibration to prevent bone loss, to increasemuscle mass, or to loosen mucus in the airways.

Vibration frequency can be in the infrasonic range (1-20 Hertz), sonicrange (20-10⁴ Hertz), ultrasonic range (10⁴-10⁹ Hertz), or thehypersonic range (>10⁹ Hertz). A number of medical devices utilizeultrasonic vibration for diagnostic or for therapeutic applications.Some devices reported to facilitate liposuction utilize ultrasonicvibration at high frequencies. These high frequencies can cause tissuetrauma and can be disadvantageous for body contouring procedures.

When autologous grafting is performed to augment the size or correctmajor body contour defects, such as micromastia, mastectomy, orlumpectomy deformities, filling the deficiency with graft tissue is notsufficient. Instead, the fibrous scar and any restrictive fibrovascularstructural framework of the tissues should also be loosened toaccommodate the additional volume. While using external expansion toprepare the recipient site to that effect such as disclosed in U.S. Pat.No. 8,066,691, and/or using devices that can percutaneously mesh expandthe tissues to be enlarged, such as disclosed in U.S. Pat. Nos. D796,671and D801,523 and U.S. Patent Publication 20150032143, the expansion isstill limited.

It would be beneficial to improve the space for the graft and improvediffusion and flow of non-Newtonian fluids to facilitate the insertionand improve the dispersion of the graft particles (The Lipoaspirate is aNon-Newtonian fluid).

Vibrating handpieces can currently be found in novelty items commonlyused for personal massage (e.g., U.S. Pat. Nos. 3,370,583 and5,925,002). However, these handpieces are not designed to connect tosurgical instruments and they lack the many features necessary for FDAapproved surgical devices such as autoclave sterilizable, safe enough tobe introduced inside patients, etc. Further, these handpieces are notdesigned to connect to liposuction cannulas and cannot effectively beused for liposuction or other body contouring surgical procedures.

A number of small electric devices use eccentric rotating masses (ERM)to produce desired vibrations. However, vibrators that have the ERMdirectly coupled to the electric rotating engine, such as alarm buzzersand small household items, are often limited in size and power. Larger,more powerful engines directly connected to ERM need very robustconstructs (extra strong bearings, fasteners, dampeners, etc.) toprotect them from vibratory wear and tear damage.

SUMMARY OF THE INVENTION

The present invention overcomes the problems and deficiencies of theprior art. The present invention provides a vibrating device thatloosens or breaks up tissue at an optimized rate and frequency, therebyeffectively striking the balance between avoiding tissue trauma andnegatively impacting tissue integrity while providing surgicaleffectiveness. The devices of the present invention also break up/loosentissue in a region larger than the cannula diameter withoutdisadvantageously increasing the size of the surgical incision used toaccess the body cavity. This is achieved by the selected vibratorymotion of the device, along with the accompanying drive system andvibration dampening system, while avoiding the disadvantages anddeficiencies of electromechanical transducers that use alternatingcurrent and magnetic fields to cause a reciprocating movement of thecannula, back-and-forth motion of cannulas, that do not use harmonic orpure vibration, transverse arcuate oscillations and back-and-forthmotion of a piston that generate both oscillations and head on impactterminal vibrations.

In accordance with one aspect of the present invention, a vibrating handheld surgical instrument for loosening tissue of a patient forliposuction or body contouring procedures is provided, the instrumentcomprising a motor and a rotating flexible shaft having a first end anda second end. The first end is operatively connected to the motor shaft.A vibration actuator includes an eccentric rotating mass operativelyconnected to the second end of the rotating flexible shaft. An endeffector for engaging tissue is operatively connected to the vibrationactuator, wherein the motor rotates the eccentric mass to cause the endeffector to vibrate to loosen tissue.

In some embodiments, the end effector is permanently connected to thevibration actuator; in other embodiments, the end effector is removablymounted to the vibration actuator.

In some embodiments, the end effector comprises a cannula having atleast one opening at a distal portion and a lumen for one or both ofinjecting fluid into the patient and/or aspirating tissue from thepatient.

In some embodiments, the end effector is aligned with a longitudinalaxis of the rotating shaft; in other embodiments the end effector isoffset from the longitudinal axis of the rotating shaft.

In some embodiments, the instrument includes a dampening mechanismextending between the housing for the motor and the vibration actuatorto dampen vibration of the end effector and connect the motor to thevibration actuator. In some embodiments, the dampening mechanism caninclude a first spring positioned over the shaft and a second staticspring positioned over the first spring.

In some embodiments, a first coupler is connected at one end to a shaftof the motor and at the other end to a shaft on which the rotatingeccentric mass rotates.

In some embodiments, a microcontroller is configured to selectivelyadjust at least one of a frequency or an amplitude of harmonic or pure(true) vibration of the vibration actuator. In some embodiments, themicrocontroller has a sensor and a servo control mechanism whichreceives information that allows it to tune the vibration of the devicewith the native vibration frequency of the treated tissues in order toreach or avoid resonance.

In some embodiments, the rotating eccentric mass imparts purely avibratory motion to the end effector; in other embodiments, the rotatingeccentric mass imparts reciprocal motion to the end effector inconjunction with the vibratory motion imparted to the end effector.

In accordance with another aspect of the present invention, a vibratinghand held surgical instrument for loosening tissue of a patient forliposuction or body contouring procedures is provided, the instrumentcomprising a cannula having a lumen for one or both of fluid injectioninto the patient or aspiration of tissue from the patient, a motor and avibration actuator operatively connected to the motor, the motoractuating the vibration actuator to impart vibratory motion to thecannula so vibration is in multiple axes.

In some embodiments, the motor further imparts reciprocal motion to thecannula in conjunction with the vibratory motion.

In some embodiments, the cannula is removably mounted to the vibrationactuator.

In some embodiments, the vibration actuator includes a shaft and arotating eccentric mass mounted on the shaft. In some embodiments, thecannula is offset from a longitudinal axis of the shaft.

In some embodiments, the motor is directly coupled to the eccentricrotating mass in the vibration actuator and the dampening componentprotects the operator hand through a passive coil.

In some embodiments, the additional reciprocating motion is actuated bya separate solenoid mechanism connected to or interacting with thevibrating component.

In accordance with another aspect of the present invention, a method forperforming loosening of soft tissue for liposuction or body contouringprocedures is provided comprising: a) providing a hand held devicehaving a motor, a vibration actuator operatively connected to the motorand a cannula operatively connected to the vibration actuator; and b)actuating the motor to effect rotation of the vibration actuator toeffect vibration of the cannula in tissue, wherein an operator of thedevice is shielded from vibrations by a dampening mechanism connectingthe motor to the vibration actuator.

In some embodiments, the method further comprises the step of extractingthrough the cannula fat dislodged from the soft tissue by vibrations. Insome embodiments, the method further comprises the step of injectingfluids, therapeutic agents or a graft into the soft tissue during orafter the vibrations.

In some embodiments, the method further comprises the step of insertinga rod or a tissue file to loosen the fibrovascular structural frameworkof the treated tissue and to also induce inflammatory reactions that caninduce tissue shaping and remodeling.

In some embodiments, the method further comprises the step ofselectively adjusting at least one of a frequency or an amplitude of thevibrations.

In some embodiments, the gripping portion around the motor has adampening cover comprising rubber, foam, ribs, or other geometricaldesigned three dimensional structure that can further reducetransmission of the vibrations to the surgeon's hand.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1 is a perspective view of one embodiment of the device of thepresent invention;

FIGS. 2 and 3 are side views of the device of FIG. 1 with a portion ofthe drive mechanism housing and the vibration actuator housing removedto show internal components;

FIG. 4 is an enlarged view of internal components of the device of FIG.1 showing the springs of the dampening mechanism and the eccentricrotating mass of the vibration mechanism;

FIG. 5 is an enlarged view of internal components of the device of FIG.1 with the static spring removed to show the flexible rotating shaftspring;

FIG. 6A is an enlarged perspective view showing a coupling of the endeffector to the vibration actuator in accordance with an alternateembodiment of the present invention;

FIG. 6B is an enlarged perspective view similar to FIG. 6A showing analternate embodiment of the coupling for the end effector and vibrationactuator;

FIG. 6C is an enlarged perspective view similar to FIG. 6A showinganother alternate embodiment of the coupling for the end effector andvibration actuator;

FIG. 7A is an enlarged perspective view of an alternate embodiment of acoupling for removable connection of the end effector to the vibrationactuator, the clamp shown in the open position for attachment or releaseof the end effector;

FIG. 7B is a view similar to FIG. 7A showing the clamp in the closed(clamping) position to secure the end effector to the vibrationactuator;

FIG. 8A is an enlarged perspective view of an alternate embodiment of acoupling for removable connection of the end effector to the vibratoractuator, the coupling shown in the position for attachment or releaseof the end effector;

FIG. 8B is a view similar to FIG. 8A showing the end effector attached(secured) to the vibration actuator;

FIG. 9A is an enlarged perspective view of the connector of the deviceof FIG. 1 for connecting the motor shaft and the eccentric rotating massshaft;

FIG. 9B is a view similar to FIG. 9A showing attachment of the rotatingshaft spring to the spring extension of the connector;

FIG. 10 is an enlarged view showing the eccentric rotating mass androller bearings of the device of FIG. 1 ;

FIG. 11A is an enlarged side view showing an alternate embodimentwherein the eccentric rotating mass of the device imparts a vibratoryand reciprocal motion, the eccentric rotating mass shown in the positionwherein the sleeve and cannula are in the backward (proximal) position;

FIG. 11B is a view similar to FIG. 11A showing the eccentric rotatingmass rotated to a second position wherein the sleeve and cannula are inthe forward (distal) position;

FIG. 12A is a view similar to FIG. 11A showing an alternate embodimenthaving ball bearings to reduce friction in the reciprocal movement ofthe outer sleeve;

FIG. 12B is a view similar to FIG. 12A showing the rotating mass rotatedto a second position wherein the sleeve and cannula are in the forwardposition;

FIG. 13A is a side view of an alternate embodiment of the device of thepresent invention having an offset end effector;

FIG. 13B is a side view of another alternate embodiment of the device ofthe present invention having an offset end effector;

FIG. 14A is a side view of an alternate embodiment of the presentinvention having an offset end effector in a device that imparts avibratory and reciprocal motion, the eccentric mass shown in theposition wherein the cannula is in the forward (distal) position;

FIG. 14B is a view similar to FIG. 14A showing the rotating mass rotatedto a second position wherein the sleeve and cannula are in the backward(proximal) position;

FIG. 15A is a side view of an alternate embodiment of the device of thepresent invention having an offset end effector and a gear mechanism,the device imparting a vibratory and reciprocal motion, and the cannulashown in the distal position;

FIG. 15B is a view similar to FIG. 15A showing the cannula in theproximal position;

FIG. 16A is a side view of an alternate embodiment of the device of thepresent invention having an offset end effector and magnets for movingthe end effector, the device imparting a vibratory and reciprocalmotion, and the cannula shown in the distal position;

FIG. 16B is a view similar to FIG. 16A showing the cannula in theproximal position; and

FIG. 17A is a side view of an alternate embodiment of the device of thepresent invention having an offset end effector and a solenoid mechanismfor moving the end effector, the device imparting a vibratory andreciprocal motion, and the cannula shown in the proximal position.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention provides a vibrating device (instrument) forperforming surgical procedures such as liposuction, autologous graftingand other body contouring applications. The devices of the presentinvention in general include a handpiece/housing containing the motorfor imparting vibration, a vibration mechanism/vibration actuator thatproduces the vibration, a dampening mechanism between the motor andvibration mechanism to dampen the vibration and an end effector attachedto the vibration mechanism for engaging body tissue of the patient.Actuation of the motor rotates the motor shaft to thereby rotate theshaft supporting the vibration mechanism which rotates to effectvibration of the end effector, e.g., a cannula, to loosen or break uptissue. Various embodiments of these devices and theirmechanisms/components are described in detail below. Note the terms“device” and “instrument” are used interchangeably herein.

In preferred embodiments, the end effector is in the form of a cannulaand tissue is aspirated through a lumen of the cannula and/or fluid isinjected through the lumen of the cannula. This is also discussed indetail below

Various couplings to secure the end effector to the vibration actuatorare described herein. In some embodiments, the end effector isnon-removably (permanently) attached to the vibration actuator; inalternate embodiments, the end effector is removably attached to thevibration actuator. These various couplings are discussed in detailbelow.

In some embodiments, the end effector, e.g., cannula, is aligned withthe longitudinal axis of the device. In alternate embodiments, the endeffector is offset from the longitudinal axis, thus, in some versions,shortening the overall length of the device. These various embodimentsare discussed in detail below.

The present invention provides a handheld device (instrument) thatdelivers to the end effector, e.g., cannula, a true harmonic vibrationsimilar to the tip of a tuning fork. In doing so, the cannula tip coversa circular surface area much wider than the cannula and thereforepotentially harvests fat out of a wider area. This allows the surgeon toharvest from a wide surface despite having a small cannula introducedthrough a concealed small puncture wound entry site. Stated another way,the same size incision can be used while providing a wider range oftissue harvesting. Furthermore, innocuous entry sites allow the surgeonif desired to use many sites which, with crisscrossing paths, that cansuction more evenly and more effectively a particular anatomic area. Bysimultaneously covering a much wider footprint area, the effect inconcept is similar to catching fish with a wide net compared to a spear.Furthermore, the vibration loosens the fibrous scaffold of the tissue,so they can better re-drape and help avoid the surface contour defectcomplications.

In preferred embodiments, the device uses low frequency true mechanicalvibration in the 10-10³ Hertz range for liposuction and for additionalreconstructive surgical procedures. In one embodiment, for example aharmonic vibrating handpiece may deliver this therapeutic vibrationthrough one or more routes and at one or more intensity levels. Otherranges are also contemplated.

The low frequency mechanical vibration is advantageous for liposuctionprocedures which effectively loosen the tissue for removal by aspirationthrough the liposuction cannula.

For autologous grafting to augment the size or correct major bodycontour defects, such as micromastia, mastectomy, or lumpectomydeformities, the present provides for loosening the restrictivefibrovascular structural framework of the tissues to accommodate theadditional volume. Augmenting the size improves the procedure sincemerely filling the deficiency with graft tissue is insufficient. Thisaugmentation is achieved by the low frequency mechanical vibration ofthe devices disclosed herein which effectively loosen the structuralframework to allow it to expand and make room for the grafts.Furthermore, the vibration improves the diffusion and flow ofnon-Newtonian fluids which facilitates the insertion and improves thedispersion of the graft particles (The Lipoaspirate is a Non-Newtonianfluid).

The lipoaspirate fluid obtained by liposuction contains a number of celltypes in addition to the fat cells, or adipocytes. When lipoaspirate isused for fat grafting, it is believed that the active componentsresponsible for the tissue augmentation are the stromal vascularfraction (SVF), or the adipose derived stem cells (ADSC) that matureinto new fat, while most of the re-grafted adipocytes fail torevascularize and die. The vibration of the tissue during harvesting bythe devices of the present invention loosens these smallundifferentiated cells that typically accompany the capillaries andtherefore result in collecting a larger proportion of these activecomponents of fat transfer. This is akin to better shaking the tree toget more apples.

Furthermore, these low frequency mechanical vibrations of the devicesdisclosed herein loosen the structural framework while resulting in lessdamage to the vascular network than the percutaneous cutting and meshingtechniques. In some embodiments, pure harmonic vibration, e.g., devoidof the back-and-forth jackhammering end strikes of the PAL and/or of thepiston-based devices, can result in less trauma to the tissues, whilestill rendering them more plastic, deformable, and moldable.Accordingly, in preferred embodiments the surgical device delivers atrue low frequency mechanical vibration. A pure or true vibratory motionas defined herein means vibration in multiple axes. The multiple axesare perpendicular or transverse to the longitudinal axis of the cannula.In reciprocal (back and forth) motion, the device moves along thelongitudinal axis. In oscillatory motion, the vibration is in one axis,like a pendulum. In the pure vibratory motion of the present invention,the vibration is like a tuning fork or a piano string, vibrating alongits length. The pure vibration occurs upon actuation and is not a resultof impact as in reciprocal motion in which some vibration might occurwhen the tip impacts tissue.

Furthermore, in some embodiments, the system allows for control of thevibration amplitude and frequency and, thus, a physician may tune thesame in order to resonate with the transducer device such as the cannulaand the treated tissues. Similarly, depending on tissue resilience andtoughness, some embodiments may provide a similar level of control overthe frequency, amplitude and the strength of the vibration.

In some embodiments, the pure harmonic vibration of the devicesdisclosed herein may be delivered through a shield like transducerapplied externally to the skin in order to loosen and to accelerate thediffusion of the injected fluids and the suspended particles.Additionally, or alternatively, the vibration may be deliveredinternally to deeper sites and multiple planes by inserting a solid rodlike or file like dissecting probe to loosen the internal structuralfibrous framework.

In some embodiments, the vibrating device may further include aliposuction cannula (as the end effector), whereby the vibration mayfacilitate the loosening of the fat lobules off their fibrousattachments and their capture by the cannula. Similarly, vibration ofthe cannula used for grafting may help disperse the graft, and withoutexcessive trauma, loosen the restrictive structures in order to makeroom and accommodate for the graft. Still in other embodiments, thevibrating member can act as a tissue file or rasp to induce a controlledinflammation and injury that can result in scarring fibrosis andshrinking of the tissue envelope and help in lifting, rejuvenating, andremodeling various tissues such as the pendulous or misshaped breast.The foregoing are some examples of surgical uses as uses in othersurgical procedures are also contemplated.

Experiment 1

A scientific evaluation of the harvesting efficiency and the quality ofthe liposuctioned fat obtained with a vibrator hand piece connected to aliposuction cannula according to one embodiment (FIG. 1 ) of the presentdisclosure. This device was compared with the PAL (power assistedliposuction device) and performed liposuction on both sides of the samepatient. In this experiment, the harmonic vibrating handpiece device wasused on one side, and the PAL on the other side. Using a similarliposuction vacuum source and harvesting cannula on both devices, theamount of fat harvested over 12 minutes of liposuction was recorded anda sample tissue sent to a lab for stem cell analysis. It was found thatliposuction with the harmonic vibrating hand piece was at least 30-45%more efficient than the PAL liposuction in terms of amount of fatharvested per minute of liposuction. Furthermore, there were about also30-45% more SVF and ADSC per milliliter of liposuctioned fat in thesample collected with the harmonic vibrating handpiece than with thePAL.

This experiment evidences that vibrations produced according toembodiments of the present disclosure would loosen up the soft tissuesand also cause more release of their mesenchymal stem cell contents. Italso evidences that a vibrating cannula tip according to embodiments ofthe present disclosure would have a wider zone of harvest than a cannulapistonning back and forth in the same channel, resulting in greaterefficiencies and harvesting more fat per stroke and per minute.Furthermore, on long term evaluation, the harmonic liposuction of thedevices of the present invention using pure vibration resulted in bettersurface contour and more even tissue re-draping and shrinking than thePAL liposuction.

Various vibration frequencies and amplitudes were also found to havedifferent effects that that may benefit different applications andrequirements. For instance, larger amplitudes may be more efficient atlipoharvesting, but the use of larger amplitudes along with largerfrequencies may cause too much trauma to delicate tissues and might bedetrimental to the integrity of the recipient fibrovascular scaffoldrequired for successful engraftment. The frequencies of the presentinvention achieve this optimal balance of efficiency and reduced trauma.

Furthermore, high frequencies, regardless of amplitude, may selectivelyharvest more adipose derived stem cells. Accordingly, some embodimentsmay be dynamic to adjust and tune the vibration frequency andcorresponding amplitude depending upon the particular clinicalrequirements.

Referring now to the drawings and particular embodiments of the presentdisclosure, wherein like reference numerals identify similar structuralfeatures of the devices disclosed herein, there are illustrated severalembodiments of the hand held surgical devices (instruments) of thepresent invention. With initial reference to FIGS. 1-3 , the hand helddevice in accordance with one embodiment of the present invention isillustrated and designated by reference numeral 10. Device 10 includesa) a drive mechanism, also referred to as the drive system or enginesystem, containing the drive components; b) a vibration mechanism, alsoreferred to as a vibration actuator, containing vibration components toeffect vibratory motion; c) a dampening mechanism, also referred to as adampening/connector system, containing the dampening components whichdampens the vibration and also provides a connector mechanism forconnecting the engine with the vibration actuator; d) an end effector,such as a cannula, which engages the patient's tissue and is operativelyconnected to the vibration actuator; and e) aclamping/connecting/component for operatively connecting the endeffector to the vibration actuator. Each of thesystems/mechanisms/components is discussed in detail below. Note as usedherein, the term “connected” or “operatively connected” means eitherdirect connection of the components or indirect connection wherecomponents are interposed between the two components but the twocomponents are nevertheless joined/connected to interact.

In use, actuation of motor 18 causes rotation of eccentric rotating mass42 via rotation of the flexible shaft 34. This causes vibration of thecannula 52 to loosen tissue. Tissue can be aspirated through the lumenin the cannula 52 during the procedure via one or more openings in thedistal region of the cannula communicating with the lumen. The device 10(as well as the other devices disclosed herein) can be used forliposuction, autologous grafting, body contouring procedures or forother surgical procedures where loosening tissue or breaking up tissueto re-structure their shape via the vibratory motion of the devices isbeneficial.

Turning first to the drive system, the system (engine components)includes a motor 18 contained in drive system housing 16. The drivesystem housing 16 also functions as the “handpiece” which the clinicianholds during the surgical procedure, thus providing a handheld device.The motor can be an electric motor or, alternatively, a pneumaticrotating motor with the engine converting the hydraulic pressure into arotational motion. In the embodiment of FIGS. 1-3 , the motorillustrated is a brushless motor by way of example. The enginecomponents further include a power source such as a battery (which insome embodiments can be sterilizable) which is enclosed in the housing16 or alternatively a plug for connection to an external power source.In the embodiment of FIGS. 1-3 , a cable 24 is connected to an externalpower source/controller. The engine component can further includevarious gauges, sensors, control mechanisms and switches for the motor.

Additionally or alternatively to a battery, the electric engine can usea power controller in the hand piece with electric wiring delivering thepower and the feedback electric circuitry to the transformer or controlmodule. In such embodiments, the power regulator may be located outsidethe surgical field. Such embodiments may allow for the display of thevibration frequency (e.g., correlated to engine rpm).

The drive system (motor) in some embodiments can be actuated by use of afoot switch for the operating surgeon. Additionally or alternatively, amanual control on the handpiece can activate the drive system.

The handpiece is ergonomically designed to comfortably fit in thesurgeon's hand. It can be covered with a dampening rubber with ribs orcushions to reduce transmission of the vibrations to the surgeon's handduring use.

With continued reference to the embodiment of FIGS. 1-3 , a manualcontrol 20, accessible to the clinician, is positioned on housing 16.The control 20 can be in the form of a lever, button, etc. for actuationby the surgeon to activate the motor for rotation of the motor shaft toeffect vibration as described below. A motor plate 22 adjacent a distalregion of the motor 18 secures the motor 18 within housing 16 andprotects it from having to bear the forces required to drive theeffector through the tissues. Cable 24, which can have a pin connectionas shown, extends proximally through an opening in the housing 16 andconnects the motor 18 to an external power source or controller (notshown).

Note as used herein, the term “proximal” refers to theportion/region/component closer to the user and the term “distal” refersto the portion/region/component further from the user during use.

Further note the term “about” as used herein means±(plus or minus) 15%of the numeric value provided.

Cylindrical housing 40 is positioned distal of drive system housing 16and spaced slightly distally axially therefrom. In the illustratedembodiment, the housing 40 has the same outer diameter as thecylindrical housing 16, although it could have a larger or smallerdiameter. The cylindrical housing contains the vibration actuator. Morespecifically, positioned within vibration housing 40 is a motorizedeccentric rotating mass (ERM) 42 that mechanically generates a purevibratory effect (e.g., harmonic vibrations) without pistons movingback-and-forth and without the more complex piezo-electricelectromechanical transducers that use alternating current to cause theoscillatory motion. The vibration amplitude of such a construct is afunction of the mass and its eccentricity, while the frequency is adriven harmonic vibration of the cannula if the system is forced tovibrate at the frequency of the excitation or the rpm speed of therotary engine.

Eccentric mass (eccentric weight) 42 is connected to drive shaft 46 andis hemi-disc shaped, rotatable in cavity (channel) 41 (see FIGS. 4 and10 ) and has an ear 43 (FIG. 10 ) that fits inside a groove in housing40 that keeps the eccentric rotating mass 42 centered in the channel.Rotation of the eccentric mass 42 effects pure vibratory motion which istransmitted to the end effector. The position and eccentricity of themass may be adjusted to vary the amplitude of the vibration.

The eccentric rotating mass 42 produces the vibration. The axis of themass 42 can be held firmly between specially designed robust rollerbearings 48, on the distal and proximal sides of the rotating mass 42,configured to withstand the lateral stresses, the axial loading forces,and the vibration.

The spring rotating shaft 34 (described in detail below) is slightlyunder tension to keep the ear 43 against the track of the bearing 48 toprotect it. Spring rotating shaft 34 is connected to the rotating mass42 through the connector as described below.

In some embodiments, the eccentric rotating mass 42 weighs about 10grams to about 25 grams, the distance from the axis of rotation to thecentroid is about 5 mm to about 25 mm and the outer diameter is about 2cm to 6 cm. Note these values are given by way of example as otherweights, distances and diameters (outside these ranges) are alsocontemplated as long as they achieve the function and benefits of theeccentric rotating mass 42 of the present invention. The mass 42 issized so as not to exceed a size where the vibrating is too wide andimpractical for surgery. On the other hand, it is sufficiently sized toeffect the loosening or breaking up a sufficient area of tissue by theend effector, e.g., cannula. Note the foregoing dimensions were found tostrike the optimal balance between, on one hand, too powerful vibrationswhich were found to be potentially damaging, and on the other hand, tooweak vibrations which had minimal therapeutic effect.

The vibrator though needs to be of sufficient size and power. Larger andmore powerful vibratory forces, which can be used in some embodiments ofthe present disclosure, may use more powerful engine torque in order torotate a larger mass with significant eccentricity. Direct coupling of apowerful engine small enough to be hand held to a larger eccentricrotating mass, however, could cause excessive wear and tear andprohibitively premature fatigue failure of the electric engine componentparts. Furthermore, it is advantageous to shield the operator's handfrom these strong vibrations and wrapping the device with a dampeningmaterial while helpful, may not be sufficient. Another factor to betaken into consideration is the significant to and fro force required toadvance the cannula through the tissues.

Shielding the engine from these compressive and distractive forces addsto the longevity of the device. To that effect, some embodiments of thepresent disclosure include a dampening connector to shield the rotatingengine and the operator's hand from the strong vibrations of theeccentric rotating mass.

This dampening system/component can include a medical grade stainlesssteel flexible rotating shaft connected to the engine (motor) shaft onone end and on the other end to the shaft 46 of the eccentric rotatingmass 42 located in the vibration actuator housing 40, The flexiblerotating shaft is preferably spring-like and slightly tensed. While theflexible rotating shaft transmits the rotatory connection from theengine, a static but flexible static connecting shaft is provided tosurround the rotating shaft to counteract the rotation and prevent therest of the device from spinning. In device 10, the static connectingshaft is in the form of a spring. Alternatively, instead of a singlespring design, this static connector may consist of a number of springsor bumpers arranged in an array all around the rotating shaft such thatthey prevent counter-rotation, maintain lateral flexibility, and dampenthe vibration. For example, the static connection may comprise a springor other flexible hollow structure, such as a rubber hose, that mayenclose the rotating shaft and provide a dampening link between the handpiece component and the vibrating actuator component. This dampeningconnector component may preserve engine longevity and protect thesurgeon's hand from excessive vibration.

An additional rubber connector can be provided to envelop the rotatingshaft and the static connector and acts as a protective sealingcomponent. An insulator component shields the patient from anyaccidental electric shock transmission. The electric insulation might beat multiple levels/locations but preferably at the clamping/connectingcomponent or at the effector component.

The dampening connector may comprise a flexible rotating shaft totransmit the rotational motion to the eccentric rotating mass of thedevice with a flexible static connector wrapped around this shaft tomechanically link the engine/hand piece component to the eccentricrotating mass. This construct isolates the engine/hand piece componentof the device from the vibrations of the eccentric rotating mass.Furthermore, to protect from the compressive and distracting forces ofliposuction, the flexible rotating shaft transmitting the rotatingmotion is preferably pre-tensioned to a certain extent compared to theflexible static connector that is stiffer and not connected to themotor.

Turning now to FIGS. 4-5 , the dampening mechanism (also referred to asthe dampening connector system or components) of the device 10 of FIG. 1is shown in more detail to provide one example of the aforedescribeddampening mechanism having a rotating and static connector. Thedampening system includes a rotating shaft spring 34 which connects theshaft of motor 18 to the shaft 46 of the eccentric rotating mass 42.Spring 34 transmits the rotary connection to the engine so rotation ofthe motor shaft effects rotation of the eccentric mass shaft. A largespring 32 is positioned over, radially spaced from, the smaller rotatingshaft spring 34 and provides the static connector to counteractrotation. The spring is slightly under tension to keep the ear 43 of theeccentric rotating mass 42 against the track of the bearing 48 asmentioned above. The spring constant of the static spring 32 ispreferably about 50 lb/in to about 350 lb/in. It has been found thatabout 30 lbs force is required to prevent the vibrating head (housing40) from hitting the handpiece (housing 16). That is, less force willcause it to hit and higher force will not allow for sufficientdampening. Therefore, the spring force of the device 10 is designed toachieve the optimal balance.

A rubber foam 36 (FIG. 3 ) and/or viscoelastic element can be used assleeve over the spring, molded around the spring, and/or as couplingsbetween the spring and device housings. This will increase the effectivespring constant, provide further dampening and act as a seal. As shownin FIG. 3 , the rubber foam connector 36 covers the shaft and seals theconnection between the handpiece and the vibration actuator.

The rotating shaft spring 34 is flexible and collapsible, and istensioned to shield the engine from the driving load. The spring 34 inthe resting position of the device is extended about 2 mm to about 10mm. Less extension can cause the spring shaft to buckle if the vibratinghead and handpiece touch each other, while a greater extension leads toa high load on the motor and bearing and can cause the spring 34 tobuckle. Its spring constant is about 2/lb/in±(plus or minus) 0.5 lb·in.Higher can create damaging loads to the motor and bearings and lower cancause the shaft to fail.

The rotating shaft spring 34 is connected at opposing ends to connectors37 as shown in FIGS. 5, 9A and 9B. The proximal connector (couplingelement) 37 has a threaded hole 37 a to receive a set screw 37 b forsecurement of the proximal connector 37 that locks it into the motorshaft 19 and the distal connector (coupling element 37) has a threadedhole 37 a to receive a set screw 37 d for securement of the distalconnector 37 that locks into the eccentric rotating mass shaft 46.Distal connector 37 has a proximally extending shaft extension 39 thefits on the inner diameter at a first end of the spring shaft 34. Agroove 37 e in connector 37 locks the tail of the coil spring. Thedistal connector 37 is shown in FIG. 9B with the spring 34 positionedover the connector extension 39. The extension of the proximal connector37 extends distally to fit on the inner diameter of the shaft 34 at asecond end of the spring shaft 34.

Clamping and/or connecting mechanisms are provided to connect the endeffector to the vibrating actuator. The end effectors can be for examplehockey stick bent liposuction cannulas, similarly configuredlipografting cannulas, fluid infusion cannulas, rods, whether smooth orrough to act as tissue files, flat discs, etc. The cannulas canalternatively be L-shaped or T-shaped. Further the cannulas can be asingle or multiple, e.g., double, lumen cannulas. The double lumen canprovide, for example, fluid injection and aspiration through separatelumens so they can occur either separately or simultaneously.

In the embodiment of FIG. 1 , the end effector 52 is in the form of acannula having one or more side openings 56 (FIG. 3 ) at the distalregion, and/or a distal opening at the terminal end of the lumen, forcommunication with the lumen extending therein. The cannula 52 isoperatively connected (attached) to the vibration actuator so thevibration is transmitted to the cannula 52 to loosen tissue inliposuction, body contouring, or other surgical procedures. Cannula 52is hockey stick shaped with angled connector 58 including a luer fitting58 a (or other form of attachment) connectable to a suction/injectionsource tubing for aspirating or for injecting for example saline toswell tissue, lipoaspirate, drugs or other fluids through the lumen andout the openings 56 of the cannula 52 into body tissue. Note othershapes of the cannula are also contemplated.

Various clamping and/or connecting (coupling) mechanisms to secure theend effector 52 to the vibration actuator component will now bedescribed. In some embodiments, the end effector is permanently attachedto the vibrator actuator such as in the embodiment of FIG. 1 ; in otherembodiments, the end effector is removably/releasably attached to thevibrator actuator. The removable attachment enables use of differentsizes or type of end effectors with the same handpiece. The couplingmechanisms may connect end effectors such as a shield like external skinvibrator, a rod like internal vibrator, a file-like internal rasp, acannula for fluid infusion, liposuction or lipoinjection, etc. The endeffector in the Figures is a cannula for aspiration/fluid injection forprocedures such as liposuction, grafting and body contouring procedures,however, it should be understood that other end effectors can be usedwith the devices of the various embodiments disclosed herein.

In FIG. 1 , the cannula can be permanently attached by connectorclamping member 50 in housing 40 which applies a clamping force to thecannula at the region adjacent the bend or alternatively the cannula canbe removably/interchangeably connected to the housing 40 with a bolt/nutscrew mechanism such as shown in FIG. 8 as described below.

FIGS. 6A-8B show alternative embodiments of connectors for releasablyattaching the end effector to the vibration actuator. However, it shouldbe understood that these mechanisms could also be utilized for permanentattachment of the end effectors. Also, it should be understood thatother mechanisms can be utilized to removably or non-removably attachthe end effector to the vibration actuator.

With reference initially to the embodiment of FIG. 6A, the vibrationhousing 40 a for the vibration actuator has a screw 25 extendingdistally therefrom which is inserted into proximal opening 49 a of heador cap 49 of end effector 52 a. Head 49 can be composed of plastic. Thisthreaded engagement removably attaches the end effector 52 a to thevibrator actuator. Note cannula 52 a, with angled luer connector 58 a isidentical to cannula 52 of the embodiment of FIG. 1 . Further, exceptfor the attachment mechanism, the components of the device of FIG. 6Aare identical to the components of the embodiment of FIG. 1 so forbrevity further discussion is not warranted since the features andfunctions of device 10 are fully applicable to the embodiment of FIG.6A, the difference being the removable threaded connection.

Note the cannula is shown as hockey shaped, however, as noted above, inthe embodiments of FIGS. 1 and 6A-8B (and in other embodiments disclosedherein), the cannula can alternatively be L-shaped or T-shaped, and canbe a single or multiple lumen cannula.

The cannula, if composed of metal, can have a plastic casing thereoverto provide electrical isolation.

In the alternative embodiment of FIG. 6B, the housing 40 b for thevibration actuator has a polygonal fitting 27 extending distallytherefrom which is inserted into corresponding dimensioned proximalopening 61 of head or cap 49 b of end effector 52 b. Screw 63 extendingthrough the opening in the cap 49 a, transverse to the longitudinal axisof the device, extends through opening 27 a in fitting 27 to securethese two components (cap 49 b and housing 40 b). Note cannula 52 b hasan angled luer connector 58 b like cannula 52 of the embodiment of FIG.1 . In FIG. 6C, a pin lock secures end effector cap 49 c to vibrationhousing 40 c as it extends through opening 28 a in polygonal fitting 28which extends distally from vibration housing 40 c and is insertableinto corresponding dimensioned opening 64 in housing 49 c of the endeffector 52C. Note the fittings 27 and 28 can be shapes other than thoseshown. Note cannula 52 c has an angled luer connector 58 c like cannula52 of the embodiment of FIG. 1 . Further, except for the attachmentmechanism, the components of the devices of FIGS. 6B and 6C areidentical to those of FIG. 1 so for brevity further discussion is notwarranted since the features and functions of device 10 are fullyapplicable to the embodiment of FIG. 6B and the embodiment of FIG. 6C.

In the alternative embodiments of FIGS. 7A-8B, a clamping mechanismremovably/releasably secures the cannula to the vibration actuator. Notein FIGS. 6A-6C, the end effector is mounted via a cap or housing whichis connected to the vibration actuator; in the embodiments of FIGS.7A-8B the cannula itself (without a cap) is mounted to the vibrationhousing.

Turning first to the embodiment of FIGS. 7A and 7B, cannula 84 has anangled luer connector 86 like cannula 52 of FIG. 1 . A plastic sleeve 87is placed over portions/regions of the cannula thereover to provideelectrical insulation. The sleeve 87 can cover a part or the entirelength of the cannula 84.

The proximal end of cannula 84 is inserted into the nipple or pointedtip 82 of the housing 40 d for the vibrator actuator. The connector isshown in FIG. 7A in the unclamped (release) position. In this position,the nipple 82 provides a sufficient gap so the end effector can beremovably received (mounted) therein. Angled portion 86 extends througha gap in the housing 40 d as shown. Clamp lever 80 is in the openunclamped position. When it is desired to secure the cannula 84 onceinserted into the nipple 82, lever 80 is moved (rotated) from theposition of FIG. 7A to the clamping position of FIG. 7B. This forces thehousing to close gap G and the spacing in the nipple 82 to clamp down on(grip) the cannula 84. The locked cam thereby holds the end effectortightly in place. If it is desired to release the cannula 84, the clamplever 80 is returned to its position of FIG. 7A to open the gap/spacingso the cannula 84 can be slid out of the nipple 82 and gap in thehousing 40 d. Note the clamping force can be applied to the insulationsleeve 87 as shown in FIG. 7A, or in alternative embodiments, directlyon the cannula 84.

The embodiment of FIGS. 8A-8B is similar to the embodiment of FIG. 7A-7Bexcept that instead of a clamp lever to clamp down on the plastic sleeveof the cannula, a threaded screw is utilized for coupling the vibrationactuator to the end effector, e.g., cannula, as the tightened screwholds the cannula tightly in place. Screw 90 is inserted and tightenedthrough the opening 91. This closes the gap H so the housing 40 e andnipple 92 can clamp down on (grip) the cannula 94. The plastic sleeve 98positioned over a portion of cannula 94 and angled luer connector 96provides electrical insulation. The housing 40 e clamps down on theinsulation sleeve 98 as shown, but in alternative embodiments, can clampdirectly on the cannula 94.

Note the plastic sleeve 87 (or 98) that is locked by the claspingmechanism can have the same outer design and caliber regardless of thecaliber of the end effector utilized.

In the foregoing embodiments, the end effector, e.g., cannula, isaligned coaxial, and along the longitudinal axis of the device. The endeffector, however, in alternate embodiments, can be offset from thelongitudinal axis. This offset can be within the confines (diameter) ofthe handheld device; or, alternatively, outside the confines of the handheld device such as depicted in FIGS. 13A and 13B.

In the embodiment of FIGS. 13A and 13B, a connecting component orconnecting housing 140 is attached to the vibration actuator housing 142(which contains the eccentric rotating mass 145 identical to rotatingmass 42 and the roller bearings described above). The connectioncomponent 140 is offset from the housing 142 so the channel to receivethe end effector, e.g., cannula, 144 is radially spaced from thelongitudinal axis of the rotating shaft of the eccentric mass 145 andthe motor shaft (not shown). In this manner, cannula 144 is radiallyoffset from the longitudinal axis of the device. In FIG. 13B, the deviceincludes an additional component 146 to round off the exposed edge ofthe vibration actuator 142. The cannula 144 can be permanently orremovably connected to the housing 140. The removabilility can beprovided by having the housing 140 permanently attached to housing 142and removing the cannula from a channel in the housing 140 oralternatively having the housing 140 removably attached to the housing142 with the cannula either removably or permanently secured in housing140. Various connections can be used to attach the housing 140 andhousing 142 such as clips, screws etc. as well as the attachments, e.g.fittings, utilized in FIGS. 6A-6C, for example.

Offsetting the cannula 144 (in this and the other offset cannulaembodiments) and placing it along the side of the vibration actuatorhousing 142 has the advantage of shortening the overall length of thedevice, That is, in the embodiments wherein the cannula is aligned withthe longitudinal axis, the proximal end of the cannula extends from thedistal edge of the vibration actuator housing; in the offsetembodiments, a region 144 a of the cannula 144 is proximal of the distaledge, shortening the overall length of the device by the length ofregion 144 a. The dampening mechanism, vibratory motion, etc. of thedevice of FIGS. 13A, 13B are otherwise the same as in device 10 so thefeatures/components and functions of device 10 are fully applicable tothe device of FIGS. 13A and 13B, e.g., eccentric rotating mass,bearings, dampening mechanism, motor etc.

Vibration and Reciprocation

In the foregoing embodiments, the end effector moved in purely vibratorymotion via the rotating eccentric mass. In alternate embodiments, areciprocal motion to the end effector is provided in conjunction withthe vibrational motion. This helps to reduce the force required to beexerted by the surgeon as the surgeon pushes through tissue during thesurgical procedure. Thus, in these embodiments, the vibration actuatorinduces a to and fro reciprocation in addition to the harmonic or pure(true) vibration.

Such motion can be achieved in some embodiments by interposing anadditional piston/cylinder component that can slide back and forth overthe vibration actuator component and connect to the clamping/connectorcomponent. The back and forth excursion of this reciprocating part couldbe actuated in some embodiments by a rod and cam mechanism that might becircular, disk-like or ovoid, while its motion is constrained by thepiston/cylinder configuration and balanced by springs.

An example of a rod and cam mechanism is shown in FIGS. 11A and 11B.Rotating eccentric mass 102 is asymmetric disc-shaped with one portion(region) 104 having a reduced width (transverse dimension), as comparedto portion (region) 106 at the opposing end, to thereby provide anarrower portion. Outer sleeve 122 has a rod 124 extending inwardlytherefrom having a surface or edge 126 engaged by the camming surface106 a of wider region 106. The outer cylinder (sleeve) 122 can have arestorative spring 132 to keep the bearings 110 in contact with the camweight.

In the initial backward excursion (proximal) position of FIG. 11A, thesurface 104 a of narrower portion 104 is contiguous with or slightlyspaced from edge 126 of rod 124, but no or minimal distal force isapplied to the rod 126. When the eccentric rotating mass 102 rotateswithin cavity 108 of vibration actuator housing 120, camming surface 106a of wider portion 106 applies a force to surface 126 or rod 124 to moverod 124 and attached sleeve 122 in a distal direction (see arrow in FIG.11B). When the eccentric rotating mass 102 is rotated back to theposition of FIG. 11A, the narrow portion 104 is adjacent the rod 126 andthus the force against (camming of) rod 126 is removed. This enables thesleeve 122 to return to its proximal position. As can be appreciated, asthe eccentric mass 102 rotates, the sleeve 122 is moved to and fro (backand forth) in a reciprocating motion in conjunction with the vibratorymotion imparted to sleeve by the rotating eccentric mass 102 to therebyimpart a vibratory and reciprocal motion to the end effector, e.g.,cannula, attached to connector 136 via opening 138. Thus, in thisembodiment, the eccentric rotating mass 102 which induces vibrationsimilar to the hemi-disk of FIG. 1 , also works as a cam forreciprocating the end effector. Stated another way, the disk-likeeccentric cam 102 also functions as the eccentric rotating mass toinduce the vibration of the end effector.

Note the device of FIGS. 11A and 11B is otherwise the same as device 10of FIG. 1 and includes e.g. bearings 110 (like bearings 48), a dampeningmechanism having a rotating shaft spring 128 (like rotating shaft spring34), static connecting shaft large spring 130 (like static spring 32), amotor, etc.

The sleeve 122 could include ball bearings 134 as shown in the alternateembodiment of FIGS. 12A and 12B to reduce friction in thepiston/cylinder reciprocating motion and improve longevity of thedevice. Otherwise, the embodiment of FIGS. 12A and 12B is identical tothe embodiment of FIGS. 11A and 11B and is provided with the samereference numerals.

Note the sleeve with the rod could be an outer sleeve as shown oralternatively positioned within an outer sleeve.

FIGS. 14A-14B illustrate an alternate embodiment having an offset endeffector in a device that imparts a vibratory and reciprocal motion.

The device of FIGS. 14A-14B has a rotating eccentric mass 150 similar torotating eccentric rotating mass 140 of FIG. 11A in that it imparts avibratory motion and a reciprocating motion to the end effector. Aconnecting component or housing 152, shown schematically, is attached tothe vibration actuator housing 154 which contains the eccentric rotatingmass 140. Various ways to attach the housing 152 are contemplated. Forexample, the rod 164 connected to the housing 154 can piston in and outwhile restrained inside a channel within housing 154. To further reducefriction, this channel might include roller bearings. Additional railingmechanism parallel to the rod piston might further absorb the forces ofdriving the effector through the tissues and help with the alignment.The connection component 152 is offset from the vibration actuatorhousing 154 so the channel in component 152 which is dimensioned toreceive the cannula 155 is radially spaced from the longitudinal axis ofthe vibration actuator shaft 157 and the motor shaft (not shown). Inthis manner, cannula 155 is radially offset from the longitudinal axisof the device. The region 155 a of the cannula 155 is proximal of thedistal end of housing 154 to thereby reduce the overall length.

When the disk like rotating mass 150 is rotated from the position ofFIG. 14B where the narrower region 160 is adjacent or contiguous withthe rod 164, the end effector (e.g., cannula) 155 is moved from theproximal position to the distal position of FIG. 14A as wider region 162applies a distal force to the rod 164. Rotation of the eccentric mass150 back to the position of FIG. 14B enables the end effector 155 toreturn to the proximal position. Note the rod 164 is constrained in achannel in the vibration actuator housing 154 by a spring 157. As in theembodiment of FIG. 11A, the eccentric rotating mass in addition toproviding vibratory motion acts as a cam to impart reciprocal motion tothe end effector.

Note the extent of excursion (distal movement) is determined by theshape, e.g., height or width, of the cam component so that the dimensionof the cam can be different than that shown to increase or decrease theextent of distal movement. A seal that encloses the construct can beprovided to maintain some lubricant.

FIGS. 15A-17A illustrate alternate mechanisms for effecting reciprocalmovement of the end effector. These devices can include the motor,dampening mechanism, bearings, etc. of device 10 of FIG. 1 . In theembodiment of FIGS. 15A-15B, a gear mechanism 170 held by rollerbearings 172 causes some de-multiplication and changes by 90 degrees therotation axis to provide perpendicular cam rotation as rotation of theshaft 171 of the vibration actuator (eccentric mass) 174 about its axisrotates gear 170 a of gear mechanism 170 which rotates gear 170 b. Viathis gear mechanism 170, rotation of the hemi-circular eccentricrotating mass 174 within vibration actuator housing 173 causes rotationof an ovoid cam 178 (your arrow 178 which causes the rod 179 toreciprocate according to the eccentricity of the cam, Thus, cam 178provides a second smaller eccentric cam—which causes rod 178 to move inand out. Such reciprocation of the rod 178 causes the end effector 179,offset from the longitudinal axis of the device by connection component175 (as in the embodiment of FIG. 14A) to reciprocate. Spring 180 andcylindrical channel 182 maintain stability and alignment of the endeffector 179 and its clamping/connection mechanism 175. Rotation ofeccentric rotating mass 174 imparts vibratory motion as described abovein conjunction while rotation of the cam 174 b imparts a reciprocalmotion via the rod 178 through the gear mechanism 170. FIG. 15Aillustrates the end effector 179 in the forward (distal) position andFIG. 15B illustrates the end effector in the inward (proximal) position.

In the alternate embodiment of FIGS. 16A-16B, a magnetic system effectsreciprocal motion. More specifically, the rotating eccentric mass 186 isalso a magnet with a North Pole N on one hemi-circle and a South Pole Son the other hemi-circle. A piston-like magnet 192 constrained within acylinder 193 also has North and South Poles. When the North Pole side ofthe rotating mass comes across the North Pole side of the piston magnet192, it repels the piston thereby pushing it out which thereby pushesthe end effector 194 out (distally) as shown in FIG. 16A. As theeccentric mass 186 rotates another half turn, the South Pole comesacross the North Pole of the piston 192 to attract it in (proximally)and cause the end effector 194 to move back in (proximally) as shown inFIG. 16B. Note the end effector 194 is offset in the same manner as theend effector in FIG. 14A. The rotating eccentric mass 186 imparts both avibratory and a reciprocal motion to the end effector as it rotates.

In the alternate embodiment of FIG. 17 , an electrically driven solenoid200 is connected to the vibration actuator 202 to cause the end effector204 to move back and forth (reciprocate). Thus, the electro magneticsolenoid mechanism imparts reciprocal motion as the hemi-circulareccentric rotating mass 206 imparts vibratory motion as it rotates.Although the use of the solenoid adds the complexity of a separateelectric set up to control the solenoid, it requires fewer moving partsand puts less strain on the existing moving parts. It also saves theflexible rotating shaft from additional torque load.

In alternate embodiments of either the sole vibration or vibration withreciprocal motion, the motor can be directly connected to the eccentricrotating mass and in some embodiments positioned in the housing for thevibration actuator such as in the housing 40 of FIG. 4 . In suchembodiments, the motor may vibrate. The vibration of the motor could bedampened by its clamping mechanism. Allowing the motor to vibrate maycause more wear and tear of the engine and shorten its life, but mayreduce resources by eliminating the flexible rotating shaft. Thedampening component in such embodiments can include coils such as thecoil shaft 32 of FIG. 4 or rubber bumpers sleeves that shield thesurgeon's gripping part of the hand piece from the vibration. In some ofthe embodiments wherein the motor is directly connected to the eccentricrotating mass, the rotating shaft spring need not be provided and apassive spring (coil) is provided to dampen vibration and protect theoperator's hand.

The rotating mass can be designed to have an adjustable eccentricity inorder to modulate the oscillating force. Moreover, a power control unit(microcontroller) could induce different vibration frequencies anddifferent vibration amplitudes to provide different effects, bothbiologic and mechanical. When the vibration frequency resonates with theendogenous vibration frequency of the cannula, this can result in aharmonic vibration pattern that markedly increases the amplitude of thevibration and significantly widens the harvesting surface area comparedto a device that achieves unidimensional harvesting, Thus, the device(s)of the present invention can be considered a three-dimensionalharvester. Some advantages can include: i) efficiency in harvestingmilliliters/minute/stroke; ii) selective harvesting of stromal vascularfraction; iii) efficiency in loosening and atraumaticallyre-arranging/re-orienting/reorganizing the extracelluar fibrovascularscaffold that gives shape to soft tissues and thus helps in re-shapingtissues whether by contracting them, expanding them or rendering themmore malleable so that they can be molded; and/or iv) achieving othereffects, such as local inflammation, induction of fibrosis collagensynthesis, blood flow (circulatory effect, both short and long term),capillary and nerve fibers disruption, or the like.

In some embodiments, an electronic control component includes amicrocontroller to control the operation of the engine component. Insome embodiments, the microcontroller sends electronic control signalsto the engine component to start, stop, and adjust the speed and/powerof the engine component. In some embodiments, the handheld componentincludes a user interface in communication with the microcontroller. Theuser interface may include input mechanisms, such as a touch screen,buttons, switches, keyboard, or a combination thereof, for an operatorto control the operation of surgical handpiece. In some embodiments, theuser interface displays the current vibration parameters to theoperator, such as frequency, amplitude, power, speed of the motor,duration, and/or other parameters. The user interface may display aselection these parameters used in the current vibration procedure. Theuser interface may also display a selection of these parameters used inone or more previous vibration procedures.

In some embodiments, the mechanical vibration is continuously appliedfor a period of time. In some embodiments, the mechanical vibration isintermittently applied for a period of time. In some embodiments, thefrequency, amplitude, and duration of the mechanical vibration deliveredby the surgical handpiece may be manually adjusted by the operator orautomatically adjusted according to a pre-programmed procedure saved ina non-transitory memory of the electronic control component.

Although the apparatus and methods of the subject disclosure have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentdisclosure as defined by the appended claims.

What is claimed is:
 1. A vibrating hand held surgical instrument forloosening tissue of a patient for liposuction or body contouringprocedures, the instrument comprising: a motor having a rotating shaft;a rotating flexible shaft having a first end and a second end, the firstend operatively connected to the shaft of the motor; a vibrationactuator including an eccentric rotating mass operatively connected tothe second end of the rotating flexible shaft; and an end effector forengaging tissue, the end effector operatively connected to the vibrationactuator, wherein the motor rotates the eccentric mass to cause the endeffector to vibrate to loosen tissue, wherein the motor is contained ina housing and the instrument further comprises a dampening mechanismextending between the housing and vibration actuator to dampen vibrationof the end effector and connect the motor to the vibration mechanism. 2.The surgical instrument of claim 1, wherein the end effector comprises acannula having at a distal portion and lumen for one or both ofinjecting fluid into the patient or aspirating tissue from the patient.3. The surgical instrument of claim 1, wherein the end effector isaligned with a longitudinal axis of the rotating shaft.
 4. The surgicalinstrument of claim 1, wherein the end effector is offset from thelongitudinal axis of the rotating shaft and offset from a rotating shaftof the eccentric rotating mass.
 5. The surgical instrument of claim 4,wherein the vibration actuator is contained within a housing, and theend effector is offset from the housing.
 6. The surgical instrument ofclaim 1, wherein the flexible rotating shaft comprises a first springand the dampening mechanism includes the first spring and a secondstatic spring is positioned over the first spring.
 7. The surgicalinstrument of claim 1, further comprising a first coupler connected atone end to the shaft of the motor and the other end to the flexibleshaft and a second coupler connected at one to the flexible shaft and atthe other end to a shaft on which the rotating eccentric mass rotates.8. The surgical instrument of claim 1, further comprising amicrocontroller configured to selectively adjust at least one of afrequency or an amplitude of harmonic vibration of the vibrationactuator.
 9. The surgical instrument of claim 1, wherein the rotatingeccentric mass upon rotation imparts reciprocal motion to the endeffector in conjunction with the vibratory motion imparted to the endeffector.
 10. The surgical instrument of claim 1, further comprising asolenoid to effect reciprocal movement of the end effector.
 11. Avibrating hand held surgical instrument for loosening tissue of apatient for liposuction or body contouring procedures, the instrumentcomprising: a motor having a rotating shaft; a rotating flexible shafthaving a first end and a second end, the first end operatively connectedto the shaft of the motor; a vibration actuator including an eccentricrotating mass operatively connected to the second end of the rotatingflexible shaft; and an end effector for engaging tissue, the endeffector operatively connected to the vibration actuator, wherein themotor rotates the eccentric mass to cause the end effector to vibrate toloosen tissue; wherein the end effector is removably mounted to thevibration actuator.
 12. A vibrating hand held surgical instrument forloosening tissue of a patient for liposuction or body contouringprocedures, the instrument comprising: a cannula having a lumen for oneor both of fluid injection into the patient or aspiration of materialfrom the patient; a motor; and a vibration actuator operativelyconnected to the motor, the motor actuating the vibration actuator toimpart vibratory motion to the cannula so that the vibration is inmultiple axes, wherein the cannula is removably mounted to the vibrationactuator.
 13. The surgical instrument of claim 12, wherein the motorfurther imparts reciprocal motion to the cannula in conjunction with thevibratory motion.
 14. The surgical instrument of claim 12, wherein thevibration actuator includes a shaft and a rotating eccentric massrotatable mounted to the shaft, the cannula is offset from alongitudinal axis of the shaft.
 15. The method of claim 12, wherein thevibration actuator includes a rotating eccentric mass.
 16. A method forperforming liposuction or loosening of soft tissue comprising: a)providing a hand held device having a motor, a vibration actuatoroperatively connected to the motor and a cannula operatively connectedto the vibration actuator; b) actuating the motor to effect rotation ofthe vibration actuator to effect vibration of the cannula in tissue; c)wherein an operator of the device is shielded from vibrations by adampening mechanism connecting the motor to the vibration actuator; d)extracting through the cannula fat dislodged from the soft tissue byvibrations.
 17. A method for performing liposuction or loosening of softtissue comprising: a) providing a hand held device having a motor, avibration actuator operatively connected to the motor and a cannulaoperatively connected to the vibration actuator; b) actuating the motorto effect rotation of the vibration actuator to effect vibration of thecannula in tissue; c) wherein an operator of the device is shielded fromvibrations by a dampening mechanism connecting the motor to thevibration actuator; d) injecting a graft into the soft tissue during orafter vibrations of the cannula.
 18. The method of claim 16, furthercomprising selectively adjusting at least one of a frequency or anamplitude of the vibrations.
 19. The method of claim 16, furthercomprising the step of injecting fluid into the soft tissue during orafter vibrations of the cannula.
 20. The method of claim 16, wherein thevibration actuator includes a rotating eccentric mass.